WO2013060322A1 - Procédé et dispositif de surveillance non invasive et de détermination de l'intensité de la douleur et de la profondeur de l'anesthésie - Google Patents

Procédé et dispositif de surveillance non invasive et de détermination de l'intensité de la douleur et de la profondeur de l'anesthésie Download PDF

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Publication number
WO2013060322A1
WO2013060322A1 PCT/DE2012/001070 DE2012001070W WO2013060322A1 WO 2013060322 A1 WO2013060322 A1 WO 2013060322A1 DE 2012001070 W DE2012001070 W DE 2012001070W WO 2013060322 A1 WO2013060322 A1 WO 2013060322A1
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Prior art keywords
depth
anesthesia
parameter
parameters
heart rate
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Ceased
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PCT/DE2012/001070
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German (de)
English (en)
Inventor
Axel Heller
Hagen Malberg
Niels Wessel
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Humboldt Universitaet zu Berlin
Technische Universitaet Dresden
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Humboldt Universitaet zu Berlin
Technische Universitaet Dresden
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Publication of WO2013060322A1 publication Critical patent/WO2013060322A1/fr
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024Measuring pulse rate or heart rate
    • A61B5/02405Determining heart rate variability
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/33Heart-related electrical modalities, e.g. electrocardiography [ECG] specially adapted for cooperation with other devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4821Determining level or depth of anaesthesia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4824Touch or pain perception evaluation

Definitions

  • the invention relates to a method and a device for the non-invasive monitoring and determination of pain intensity and depth of anesthesia during medical interventions. Monitoring the depth of anesthesia - the state of anesthesia - during an operation is one of the prior art of medical treatment.
  • the technical means for determining the depth of anesthesia are the measurement of blood pressure and heart rate; in addition, EEG signals from the brain are now also being used.
  • the resulting negative effects can cause delayed postoperative awakening, prolonged monitoring times, and cardiovascular instability.
  • the field of application of the invention is thus an anesthesia guide during medical operations on the patient, in order to avoid incorrect loading due to overdoses or underdoses of necessary medicines.
  • the document US2011 / 0137134 A1 describes a method with complex algorithmic processing of arterial pressure and heart rate data for monitoring the intraoperative pain intensity sensation for fuzzy logic-based control of infusion administration.
  • Dominant are EEG data in combination with other relevant heart rate data to determine the depth of anesthesia.
  • only anesthesia depth measurement with frequency parameters of the heart rate variability HRV is possible. New frequency ranges and new monitoring parameters are planned.
  • cardiovascular biosignals are one of the most current topics in biomedical engineering research.
  • extracorporeal derived biosignals e.g., ECG, blood pressure
  • ECG electrocardial pressure
  • blood pressure blood pressure
  • General anesthesia is a medication-induced controlled and reversible loss of consciousness with parallel pain elimination. like a induced muscle relaxation.
  • the brain is not completely turned off, so the depth of anesthesia is constantly monitored during a medical operation. As standard for the monitoring of the depth of anesthesia measurements are made, based on
  • the anaesthetized patient wears a headset with a continuous click. Each click triggers a response in the patient's brain, and the reaction is reflected in the cerebral flow curves. Quantifying the reaction is entirely possible with computer technology. The way the reaction works depends on the depth of anesthesia, which the system can measure in this way, as in the publication Wiedemann: Neuärige “Wachheitsmonitore" (Anesthesia depth with acoustic stimuli), URL: http: //www.innovations-report. de / html / reports / medicine_health / report- 17726.html. Clinically, the criteria for "too shallow or too deep anesthesia" so far difficult to judge patient-specific.
  • a device for monitoring anesthesia and depth of consciousness is described in document WO 2011/017778 A1.
  • the invention also includes a method wherein the apparatus and methods are based on the execution of at least one non-linear dynamics (NLD) analysis for monitoring continuous or evoked signals at the patient.
  • NLD non-linear dynamics
  • the invention is based on a non-linear dynamics (NLD) analyzer to improve the difference between different signal origins.
  • NLD non-linear dynamics
  • One problem is that at least two sensors are needed to estimate the depth of anesthesia.
  • the focus of the invention is directed to AEP (triggered test signals) and the associated data analysis with nonlinear dynamics (NLD) methods from EEG recordings.
  • NLD nonlinear dynamics
  • a general problem of the aforementioned prior art is thus that a pain strength measurement and assessment during anesthesia so far is not possible.
  • the known monitoring systems are not suitable for detecting the occurrence of lack of anesthetic depth or intraoperative alertness early and reliably.
  • the metrological quantification of pain intensity is missing.
  • the result is that hypnotics and sedatives are administered for safety and thus the overdose is made with all the negative consequences.
  • heart rate variability As heart rate variability or heart rate variability (HRV) is in the article: heart rate variability, Wikipedia http://de.wikipedia.org/wiki/Herzfrequenzva- riabil% C3% A4t, the ability of an organism (human, mammal) called the frequency to change the heart rhythm. Even at rest spontaneous changes in the time interval between two heartbeats occur.
  • HRV heart rate variability
  • the distance between two heart beats is usually defined as the time between the beginning of two contractions of the ventricles. This beginning of the chamber contraction appears in the electrocardiogram (ECG) as a so-called R-wave.
  • ECG electrocardiogram
  • the distance between two R waves is therefore referred to as the RR interval (to avoid confusion with the blood pressure indication RR (according to Riva-Rocci), the name NN is sometimes used).
  • the RR interval can be converted into the heart rate as a reciprocal (60 BPM ⁇ 1000 ms: 60 beats per minute ⁇ 1000 milliseconds RR distance).
  • the RR intervals are usually not the same length, but are subject to fluctuations. The quantification of these fluctuations is referred to as heart rate or heart rate variability (HRV).
  • HRV heart rate or heart rate variability
  • a heartbeat is triggered by an impulse of the sinus node as the central impulse generator of the autonomic excitation system of the heart. This, in turn, is under the influence of the superior vegetative nervous system, with an activating influence on the sympathetic nervous system. flow which, inter alia, results in an increase in the heart rate.
  • Physical and mental stress is associated with an increase in the activity of the sympathetic, to be reduced in parallel to the parasympathetic regulated body functions, such as digestion.
  • External influences stimuli
  • mental processes thoughts
  • mechanical processes hearing
  • the ECG of a heart rate monitor is still a central diagnostic procedure in cardiology. From the ECG, a so-called time series of the RR intervals can be determined. The variation of this time series can be quantified by means of different methods with regard to their strength, time scale or internal patterns. A simple statistical quantity for determining the variance is the standard deviation of the RR intervals. There are three areas (domains) that are used to analyze heart rate variability: ⁇ Time range ZB (eg standard deviation of RR intervals)
  • the fluctuations of the heart rate can be further characterized by spectral analysis. More recently, complex empirical parameters such. B. the fractal dimension used.
  • Spectral analysis is a very accurate method for determining the frequency components that make up heart rate variability. For example, it provides information about the coupling of respiration and heartbeat (ie their coherence) in the relaxed state. When respiration and heartbeat are well coupled, the spectral analysis gives a clear peak (peak).
  • the relevant measurement spectrum is divided into frequency bands in HRV research, low-frequency band LF (low frequency), high-frequency band HF (high frequency), partially plus another frequency band: VLF (Very-low frequency) band and ULF (ultra low frequency) band.
  • a parameter of the frequency range FB is the heart rate (HR).
  • HRV heart rate variability
  • heart rate variability has its origin in the function of the autonomic nervous system, in principle it is possible to detect diseases which have an effect on the heartbeat.
  • the invention is therefore based on the object of specifying a method and a device for non-invasive monitoring and determination of pain intensity and depth of anesthesia, which are designed so that the measurement of heartbeat signals and the common display of anesthetics and pain intensity during medical Interventions can be reliably and promptly given to improve the quality of the anesthesia depth profile.
  • an individualized anesthesia guide should also be sought for economic reasons, wherein
  • Biosignal analyses at least with the determination of time-domain based parameters ZB for the pain intensity P and with determination of nonlinear-based symbolic dynamics parameters SD for the depth of anesthesia D, wherein information about
  • heartbeat signals indicating the change in heart rate and heart rate variability being calculated
  • Heart rate variability is hereby considered to be the change in heartbeat duration for each heartbeat, i. is defined as a change in heartbeat-to-heartbeat interval.
  • the parameter frequency range FB can be used to display the depth of anesthesia D.
  • An associated device for the non-invasive monitoring and determination of pain intensity and depth of anesthesia according to the aforementioned method comprises according to the characterizing part of claim 9
  • a function unit for signal preprocessing in order to provide the electrical biosignals, taking account of a determined heart rate variability, on the one hand for processing into parameter time range ZB for the pain intensity P and on the other hand for processing into parameter symbolic dynamics SD for the depth of anesthesia D respectively
  • an evaluation unit having at least two signal channels, which is connected downstream of the functional unit for signal preprocessing, and the signals of the parameter time domain ZB are arranged in a first signal channel and the parameters of the symbolic dynamics signal SD in a second signal channel,
  • the evaluation unit has a functional unit for calculating the pain intensity P and a functional unit for calculating the anesthetic dose D including program-technical means stored therein, and
  • - has a decision-system functional unit, which is connected in line with the pain-strength calculation functional unit P and with the anesthesia depth-calculation functional unit D, and performs comparisons of the calculated values with detected output / target values, and
  • the display unit may be implemented as a monitor for monitoring the displayed anesthesia depth D and the indicated pain intensity P, preferably as a special anesthetic pain monitor.
  • the ECG for detecting / measuring heartbeat signals may be replaced by an external input device prior to the induction of anesthesia detected heartbeat signals and conversion of biosignals formed in electrically digital form or in parallel to comparing the pre-operative heartbeats and heartbeats during the medical operation be connected.
  • the advantage of the invention is that, in contrast to the prior art, an EEG data usage can be explicitly dispensed with.
  • an EEG data usage can be explicitly dispensed with.
  • a measurement of heartbeat signals by means of a conventional method (preferably by ECG), which are suitable for indicating the change in the heart rate and
  • a system is to be created which, in addition to the information on the depth of anesthesia, also provides information on the level of pain.
  • the device comprises a heartbeat measuring device for signal detection and, furthermore, at least one evaluation unit with functional units for biosignal analysis and functional units for forming a rule-based decision system, the execution of the biosignal analysis and the mode of operation of the decision system being based on program-technical means.
  • the evaluation unit therefore contains functional units which, in their electronic hardware structure and in their program-technical mean interactions, represent a software-supported system for monitoring the depth of anesthesia D during an operative procedure by evaluating cardiovascular biosignals and at the same time statements about the instantaneous pain intensity occurring during the procedure P indicates.
  • Characteristic segments for heart rate analysis in particular from the ECG signals of the heart rate monitor, are obtained and evaluated.
  • other signals can also be used for monitoring from the one heartbeat meter during anesthesia for cardiovascular anesthesia analysis.
  • the indicator for the depth of anesthesia D is the calculated special nonlinear parameter Symbolic dynamics SD and the indicator for the pain intensity P are the parameters time range ZB for the pain intensity P, wherein the respective parameters are assigned to functional units of the evaluation unit.
  • the invention thus describes the existence of a functional relationship between biosignals and the depth of anesthesia D and the pain intensity P.
  • the program-technical means of the evaluation unit realize a mathematical model with an evaluation of characteristic signal segments, in particular the heart rate variability of the heartbeat signals for a rule-based decision system for anesthesia guidance.
  • the following program-technical steps are carried out in the functional units of the evaluation unit:
  • the standard equipment may comprise at least one conventional arrangement for measuring heartbeat signals - a heartbeat meter.
  • 1 shows a device for the non-invasive monitoring and determination of pain intensity P and of depth of anesthesia D during medical interventions with a single arrangement for heartbeat measurement with signal detection
  • FIG. 2 shows a parameter symbolic dynamics (SD) -arcosine depth (D) -functional representation
  • Fig. 3 is a Veriaufsdarwolf the anesthesia depth D (t) during various
  • FIG. 5 is a plot of pain intensity P (t) during various periods of the perioperative phase.
  • FIGS. 1 and 2 are considered together.
  • FIG. 1 shows in general form a device 13 for noninvasive monitoring and for determining the pain severity P and the depth of anesthesia D during medical surgical interventions, wherein at least one conventional arrangement 2 for heart rate measurement and signal acquisition 3, eg an ECG, is provided.
  • a patient 1 for signal acquisition 3 of heartbeats connected to the arrangement 2 for heart rate measurement.
  • signal preprocessing 4 taking into account the heart rate variability takes place taking into account already stored in the device 13 biometric signals together with the preprocessed signals performing a biosignal analysis. 5
  • the parameter time range ZB and the parameter symbolic dynamics SD are determined from the available biosignals, wherein the symbolic dynamics parameter SD is intended to determine and display the depth of anesthesia D, while the parameter time range ZB for determining the pain intensity P and the display thereof on a monitoring unit designed as a display unit 12.
  • a decision system 6 evaluates the parameter symbolic dynamics SD and the parameter time range ZB for estimating the depth of anesthesia D and the pain intensity P and shows for monitoring appropriate statements on the continuation of the medical intervention by a user 7.
  • FIG. 2 an associated parameter symbolic dynamics (SD) - anesthesia depth (D) function representation is shown, wherein in the values of the areas SDo and Do normal heartbeat signals and an associated normal alertness level are present.
  • SD parameter symbolic dynamics
  • D anesthesia depth
  • the normal level of alertness of a patient is determined prior to induction of anesthesia, the measurement of heartbeats taking into account a determined heart rate variability HRV and its evaluation prior to induction of anesthesia as reference measurement and determination for time domain parameters ZB and symbolic dynamics parameters SD in the stage before the induction of anesthesia.
  • FIG. 2 shows a linear functional assignment of the parameter symbolic dynamic SD to the depth of anesthesia D:
  • Deviations from the depth of anesthesia Do are reproduced by a deviation of the parameter symbolic dynamics SD 0 to SD n , as a result of which the heartbeat measured values obtained can be monitored and evaluated in accordance with FIG. 2.
  • D D (t) of the depth of anesthesia D during different periods of time t1 to t6 of the perioperative phase.
  • the temporal change of the anesthetic depth level D (t) of a patient in the time intervals t1 to t6 is displayed on the monitor 12, wherein the ranges of the parameter SD with SDo, SD n and SDm are associated with areas Do, D "and Dm of anesthesia depth as shown in FIG.
  • FIG. 4 shows an associated parameter time range (ZB) - pain intensity (P) - functional representation, whereby normal heartbeat signals and an associated normal level of pain intensity - range without operative pain - are present at the values P 0 and ZB 0 .
  • Deviations from the pain intensity Po are reproduced by a deflection of the parameter time range ZBo, as a result of which the received heartbeat measurement values can be evaluated in accordance with FIG. 4.
  • FIG. 4 shows a functional assignment of the parameter time range ZB to the pain intensity P (pain intensity):
  • the range P 0 of the normal pain intensity state corresponds to the high range of the parameter time range ZBo
  • the range Pi of a slight pain intensity corresponds to the middle range of the parameter time range ZBi
  • FIG. 5 shows a progression representation of the parameter of pain intensity P during different periods of time t1 to t7 of the perioperative phase. Taking into account the assignment of the pain strengths P shown in FIG. 4 from the calculated parameter time range ZB, the temporal change in the pain intensity level P is displayed in the time intervals t1 to t7 of a patient, corresponding to the ranges of the parameter time range ZB with ZBo, ZBj and ZB S. Areas Po, Pi and P s of the pain intensity, as shown in Fig. 4 are assigned.
  • the inventive method and the associated device make it possible that due to the use of a conventional arrangement for heart rate signal measurement no additional sensor on and / or in the patient must be introduced, which means no additional risk burden for the patient 1.
  • the associated device 13 for noninvasive monitoring and for determining pain intensities P and depths of anesthesia D during medical procedures comprises, as shown in a schematic illustration in FIG. 6, at least
  • a downstream converter 9 for the conversion of the detected heartbeat signals into electrically digitized biosignals
  • a functional unit 4 for signal preprocessing in order to channel the electrical bio-signals taking into account a determined heart rate variability on the one hand for the processing in parameters PA for the pain intensity P and on the other hand for the processing in parameters symbolic dynamics SD for the depth of anesthesia D,
  • an evaluation unit 8 having two signal channels 18, 19, which is connected downstream of the signal preprocessing functional unit 4 and receives the signals of the parameter time range ZB via the first signal channel 18 and the signals of the parameter symbolic dynamics SD via the second signal channel 19,
  • the evaluation unit 8 has a functional unit 10 for determining / calculating the pain intensity curve P and a functional unit 11 for determining the calculation of the depth of anesthesia course D including program-technical means stored therein, and
  • - has a decision-making functional unit 6, which is connected in line with the pain intensity curve P function / calculation unit 10 and with the depth-of-depth detection / calculation functional unit 11, and makes comparisons of the detected / calculated values with detected output / target values , and
  • a monitor / anesthesia pain monitor 12 which is intended to display the depth of anesthesia course D and the associated pain intensity curve P and monitoring.
  • an external input device 15 with recorded heartbeat signals in the state of analgesia and without anesthesia and in electrically formed biosignals alternatively be used instead of the arrangement 2 or parallel to the arrangement 2.
  • a memory unit 16 for patient-characteristic data shown in FIG. 1 may be associated with the functional unit 3 for detecting and converting heartbeat signals and the evaluation unit 8 including the decision system 6.
  • Patient characteristic data can be eg BMX, age, sex, medication, type of medical intervention.
  • a unit 17 for problem-triggering alarm activation can be connected in addition to the monitor / anesthetic pain monitor 12 designed as a display unit and / or monitoring unit.

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  • Hospice & Palliative Care (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

L'invention concerne un procédé et un dispositif (13) de surveillance non invasive et de détermination de l'intensité P de la douleur et de la profondeur D de l'anesthésie, le dispositif (13) comprenant au moins : - un agencement (2) de détection/mesure de signaux cardiaques; - un convertisseur (9) monté en aval pour la conversion des signaux cardiaques détectés en biosignaux numérisés électriquement; - une unité fonctionnelle (4) de prétraitement des signaux, destinée à traiter les biosignaux électriques, compte tenu d'une variabilité déterminée du rythme cardiaque, pour donner d'une part des paramètres 2B pour l'intensité P de la douleur et d'autre part des paramètres SD pour la profondeur D de l'anesthésie, à partir de la variabilité déterminée du rythme cardiaque; - une unité d'analyse (8) présentant au moins deux canaux de signaux (18, 19) et reliée en aval à l'unité fonctionnelle (4) pour le prétraitement des signaux, laquelle unité d'analyse reçoit les signaux des paramètres de plage temporelle ZB via le premier canal de signal (18) et les signaux des paramètres de dynamique symbolique SD via le deuxième canal de signal (19), l'unité d'analyse (8) comprenant une unité fonctionnelle (10) pour la détermination de l'intensité P de la douleur et une unité fonctionnelle (11) pour la détermination de la profondeur D de l'anesthésie, dans laquelle sont mémorisés des moyens associés à la technique de programmation; - une unité fonctionnelle (6) pour un système de prise de décision, qui est reliée de façon conductrice à l'unité fonctionnelle (10) de détermination de l'intensité P de la douleur et à l'unité fonctionnelle (11) de détermination de la profondeur D de l'anesthésie et exécute des comparaisons entre les valeurs déterminées/calculées et des valeurs de départ/de consigne enregistrées; et - une unité d'affichage (12) sur laquelle est prévu un affichage de la profondeur D de l'anesthésie et de l'intensité P de la douleur pour permettre leur surveillance.
PCT/DE2012/001070 2011-10-28 2012-10-26 Procédé et dispositif de surveillance non invasive et de détermination de l'intensité de la douleur et de la profondeur de l'anesthésie Ceased WO2013060322A1 (fr)

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DE102011117573.7 2011-10-28
DE102011117573A DE102011117573A1 (de) 2011-10-28 2011-10-28 Verfahren und Einrichtung zum nichtinvasiven Überwachen von Schmerzstärken und zur Ermittlung von Narkosetiefen während medizinischer Eingriffe

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US9849241B2 (en) 2013-04-24 2017-12-26 Fresenius Kabi Deutschland Gmbh Method of operating a control device for controlling an infusion device
CN112006659A (zh) * 2020-08-21 2020-12-01 思澜科技(成都)有限公司 一种麻醉状态监测方法及装置
CN112006658A (zh) * 2020-08-21 2020-12-01 思澜科技(成都)有限公司 一种麻醉状态监测方法及装置
CN112006657A (zh) * 2020-08-21 2020-12-01 思澜科技(成都)有限公司 一种麻醉深度监测方法及装置

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CN112006658A (zh) * 2020-08-21 2020-12-01 思澜科技(成都)有限公司 一种麻醉状态监测方法及装置
CN112006657A (zh) * 2020-08-21 2020-12-01 思澜科技(成都)有限公司 一种麻醉深度监测方法及装置
CN112006657B (zh) * 2020-08-21 2022-08-02 思澜科技(成都)有限公司 一种麻醉深度监测方法及装置

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